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510(k) Data Aggregation
(162 days)
The IPGTFL-02 is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology:
- Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
- Laser Resection of the Prostate (LRP)
- Laser Enucleation of the Prostate (LEP)
- Laser Ablation of the Prostate (LAP)
- Transurethral Incision of the Prostate (TUIP)
- Condylomas
- Urethral strictures
- Lesions of external genitalia
- Bladder neck incisions (BNI)
- Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
- Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi with integrated detection of calculi and mucosal tissue by StoneSense module that reduces exposure of mucosal tissue to laser energy and reduces resulting damage to mucosal tissue
- Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy:
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones.
- Endoscopic fragmentation of renal calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
Gastroenterology:
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Angiodysplasia
- Polyps
- Colorectal cancer
- Biopsy
- Telangiectasias
- Gall Bladder calculi
- Telangiectasias of the Osler-Weber-Renu disease
- Biliary/Bile duct calculi
- Vascular Malformation
- Ulcers
- Gastritis
- Gastric ulcers
- Esophagitis
- Duodenal ulcers
- Esophageal ulcers
- Non Bleeding Ulcers
- Varices
- Pancreatitis
- Colitis
- Hemorrhoids
- Mallory-Weiss tear
- Cholecystectomy
- Gastric Erosions
- Benign and Malignant Neoplasm
Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
IPGTFL-02 is a desktop, portable thulium laser source and controller used with specific surgical fibers (single-use & reusable) for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
The laser system generates non-ionizing radiation which is transferred to the relevant anatomical treatment site through surgical fibers that serve as the delivery vehicle from the laser energy generator to the treatment site.
The laser system includes a universal, three-pedal footswitch that can operate in wired and wireless mode for hands-free control. The system can utilize a customer-supplied, medical grade external surgical monitor to display endoscope video as well as the device's user interface.
The laser system's front panel includes a surgical fiber connection port and a touchscreen with a user interface. The rear panel includes electrical and interface cable ports. The laser system may be placed on an optional, mobile cart. The system can utilize an auxiliary video monitor to display operating parameters.
The laser system can operate at a maximum power output of 60 watts in CW, regular and advanced Pulsed modes with a maximum frequency output of 2400 Hz and a maximum pulse energy of 6 Joules.
The laser system must be operated with the IPG Medical Surgical Fibers. The surgical fibers are flexible optical fibers that deliver the laser energy to the target tissue. The surgical fibers are the only patient-contacting components of the IPGTFL-02.
The purpose of this 510(k) is to add an optional module called StoneSense for lithotripsy procedures. During these procedures it is possible that the fiber tip loses contact or quasi-contact with the stone which is undesirable. The module is designed to detect if the object in contact or quasi-contact with the distal fiber tip is "Stone" or "Not Stone". If Stone is not detected, the system will not allow emission of the laser. The addition of Stone sense will add an indication for the device.
Also, three advanced power modes have been added:
- Fragmentation Pulse - Special pulse shape, optimized for stone ablation into large fragments.
- Minimal Carbonization Pulse - Special pulse shape for soft tissues vaporization, incision and excision with minimization of tissue carbonization.
- Enucleation Pulse - Special pulse shape, developed for enucleation procedure to maximize thermo-mechanical separation of adenomic tissue and capsule with simultaneous strong hemostasis effect.
This document provides a summary of the IPGTFL-02 device, focusing on its StoneSense module and new advanced power modes. Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study for IPGTFL-02
The IPGTFL-02 is a thulium fiber laser system with added features, including the StoneSense module for lithotripsy procedures and three new advanced power modes. The FDA clearance is based on proving substantial equivalence to a predicate device (K232568).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a dedicated table. However, it describes the purpose and function of the new features, which implicitly sets performance expectations. Based on the description, the following can be inferred:
| Feature/Parameter | Acceptance Criteria (Inferred from device description) | Reported Device Performance |
|---|---|---|
| StoneSense Module | Accurately detect if the object in contact or quasi-contact with the distal fiber tip is "Stone" or "Not Stone". | During simulated procedures, StoneSense accurately determined "Stone" or "Not Stone" compared to known values. |
| StoneSense Module | Prevent laser emission if "Stone" is not detected, reducing exposure of mucosal tissue to laser energy and damage. | Function confirmed during testing to prevent laser emission when "Stone" was not detected. |
| Fragmentation Pulse | Optimized for stone ablation into large fragments. | Ex-vivo testing confirmed efficiency for stone ablation into large fragments (compared to predicate). |
| Minimal Carbonization Pulse | Optimized for soft tissue vaporization, incision, and excision with minimized tissue carbonization. | Ex-vivo testing confirmed effectiveness for soft tissue vaporization, incision, and excision with minimized carbonization (compared to predicate). |
| Enucleation Pulse | Optimized for enucleation procedures to maximize thermo-mechanical separation of adenomic tissue and capsule with simultaneous strong hemostasis effect. | Ex-vivo testing confirmed effectiveness for enucleation, maximizing thermo-mechanical separation and strong hemostasis (compared to predicate). |
| Overall New Power Modes | Improve effect on tissue or stone without compromising safety profile. | Ex-vivo testing compared fragmentation efficiency, ablation depth, coagulation width, and carbonization grade to the predicate device, implying satisfactory performance without safety compromise. |
2. Sample Size and Data Provenance for Test Set
- Test Set for StoneSense Module: "simulated procedure with a known value of 'Stone' or 'Not Stone'".
- Sample Size: Not specified. The phrase "known value" suggests a controlled experimental setup, but the number of instances or trials is not provided.
- Data Provenance: Not explicitly stated, but likely laboratory-based (ex-vivo simulation). No country of origin is mentioned. The study is prospective in the sense that the test was conducted specifically to evaluate the device functionality.
- Test Set for New Power Modes: "Ex-vivo testing was completed to compare effects such as fragmentation efficiency, ablation depth, coagulation width and carbonization grade and coagulation of the new power modes to the predicate device."
- Sample Size: Not specified.
- Data Provenance: Ex-vivo testing, meaning performed on excised tissue or materials, not in living subjects. No country of origin is mentioned. This is a prospective test.
3. Number and Qualifications of Experts for Ground Truth
- The document does not specify the number or qualifications of experts used to establish ground truth for either the StoneSense module or the new power modes.
- For StoneSense, the ground truth was based on "known value of 'Stone' or 'Not Stone'," suggesting a predetermined classification in the simulated environment.
- For the new power modes, "effects such as fragmentation efficiency, ablation depth, coagulation width and carbonization grade" were compared. This likely involved objective measurements rather than direct expert consensus on a subjective interpretation.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the ex-vivo and simulated testing, it's possible that adjudication in the typical sense of reconciling expert opinions was not performed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being done. The studies described are non-clinical, comparing device performance metrics directly or in simulated environments, not involving human readers/operators in a comparative effectiveness study setting. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is reported.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done for the StoneSense module. The testing involved comparing "StoneSense determination of 'Stone' or 'Not Stone' during a simulated procedure with a known value of 'Stone' or 'Not Stone'." This evaluates the algorithm's ability to classify objects without human intervention in the classification process.
7. Type of Ground Truth Used for Test Set
- StoneSense Module: "Known value of 'Stone' or 'Not Stone'". This represents an objective or predetermined ground truth established within the simulated testing environment. It is not expert consensus, pathology, or outcomes data in the clinical sense.
- New Power Modes: The ground truth was based on objective measurements of characteristics like "fragmentation efficiency, ablation depth, coagulation width, and carbonization grade." This is a quantitative, measured ground truth, effectively comparing the device's output to defined physical properties.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set for any of the new features, including the StoneSense module or the advanced power modes.
9. How Ground Truth for the Training Set was Established
The document does not describe how the ground truth for any training set was established. Given the nature of the device (a laser system with a detection module and optimized pulses), it's possible that the "training" involved various experimental configurations and data collection to develop the algorithms for StoneSense and the pulse shapes, rather than a traditional medical image or clinical data training set with externally validated ground truth like pathology reports.
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(242 days)
1550nm laser:
Indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including menscus cartilage, in conjunction with an imaging modality for medical specialties including: General Surgery, Orthopedics, Podiatry, Arthroscopy and Spinal Surgery.
980nm laser:
Indicated for use to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Regenalase is a portable console that houses a fiber laser operating at 1550 nm wavelength and a diode laser operating at 980 nm wavelength. The system utilizes a wired one-pedal footswitch for hands-free laser activation. The console consists of the 1550 nm laser module, the 980 nm laser module, control electronics, optical module, air cooling, and a touch screen display.
The laser energy for the 1550 nm laser is delivered via previously cleared commercially available laser fibers. The fibers come in two different sizes.
The 980 nm laser is used with a fiber delivery system, consisting of the Universal Stage One handpiece and four different attachments.
This looks like a 510(k) summary for a medical laser system. Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics like a typical software or AI device study would. Instead, it describes various non-clinical tests and their outcomes, aimed at demonstrating substantial equivalence. The "acceptance criteria" are implied by the conformance to standards and the comparability to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1550 nm Laser: | |
| Similar thermal damage to predicate device (1470 nm laser) | "The results show that the two devices produced comparable thermal damage." (ex vivo study) "The data show that the induced damage was comparable between the subject and predicate devices for comparable energy deposition." (Thermal Performance Evaluation) |
| Pulse duration within safe and effective range (subset of predicate) | "The Subject device's pulse durations fall within the range of the Predicate device's pulse durations. All possible combinations of power and pulse duration of the Subject device are a subset of all possible combinations of power and pulse duration of the Predicate device. Therefore, there are no new additional questions of safety and effectiveness raised since all the Predicate device's possible combinations of power and pulse duration are equivalent to those of the Predicate device." |
| Pilot beam wavelength does not raise safety concerns | "The Subject device differences in pilot beam wavelengths, both being visible, do not raise any different concerns for safety." |
| General Device: | |
| Risk management adherence | "Risk management was performed according to ISO 14971 Third Edition 2019-11 Medical Devices -Application of risk management to medical devices and the FDA Guidance Document." |
| Electrical safety & electromagnetic compatibility | "The device conforms to the following standards: IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-22 Edition 3.1 2012-10, IEC 60825 Edition 2.0 2007-03." |
| Software verification and validation | "Software verification and validation testing was conducted and documentation provided as recommended by the FDA's 'Guidance for the Content of Premarket Submissions Contained in Medical Devices' and in ANSI/AAMI/IEC 62304:2006/A1:2016...results were found acceptable for software release." |
| Human factors evaluation | "Human Factors...confirmed using ANSI/AAMI/IEC 1:2015+AMD1 2020 (Consolidated Text) Medical Devices Part 1 Application of Usability engineering to medical devices...results found to be acceptable." |
| Biocompatibility of patient-contacting materials | "Biocompatibility testing was conducted...in compliance with ISO 10993-1 and the FDA Guidance...results of the tests indicated that all success criteria were met with no issues." |
| Bench testing (power output, beam quality, environmental, safety control) | "Testing shows that the device delivers set energy parameters within specifications and performs as intended." |
| Overall safety and effectiveness compared to predicate | "Comparison between the Regenalase Laser System and the predicate device shows that the Regenalase Laser System is as safe and effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The only specific "test set" mentioned in terms of data collection for performance comparison is for the thermal performance evaluation, which used "three ex vivo tissue samples." No other specific sample sizes for tests like electrical safety, software validation, or human factors are given.
- Data Provenance: The thermal performance evaluation was an ex vivo study (meaning performed on tissue outside a living organism). The country of origin is not specified, but the manufacturer is based in Marlborough, MA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. For a laser system primarily demonstrating physical effects (like thermal damage), the "ground truth" is typically the measured physical effect itself (e.g., thermal damage depth/width). There's no mention of expert human readers or reviewers establishing ground truth for performance metrics.
4. Adjudication Method for the Test Set:
This information is not provided. Given that the thermal performance evaluation relied on physical measurements rather than subjective human assessment, an adjudication method for reconciling expert opinions would likely not be relevant or necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This type of study is typically done for AI/software devices that assist human readers in tasks like image interpretation. The device being described (Regenalase Laser System) is a surgical laser, not an AI diagnostic or assistive tool for human readers. "Clinical trials were not deemed necessary," and the submission focuses on non-clinical substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
The concept of a "standalone algorithm performance" is not applicable to this device. The Regenalase Laser System is a physical medical device (a surgical laser), not an algorithm or software that performs a task independently. The device's performance is inherently tied to its physical output and how it interacts with tissue.
7. The Type of Ground Truth Used:
For the thermal performance evaluation, the "ground truth" was established by direct measurement of thermal damage in the ex vivo tissue samples. For other non-clinical tests, the ground truth was conformance to established engineering and medical device standards (e.g., IEC standards for electrical safety, ISO standards for biocompatibility).
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The Regenalase Laser System is not an AI/ML device that requires a "training set." Its development and validation are based on engineering principles, physical testing, and comparison to a predicate device.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for this type of device.
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(210 days)
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indication: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology: • Ablation ofBenign Prostatic Hyperplasia (Hypertrophy) [BPH] • Laser Resection of the Prostate (LRP) • Laser Enucleation of the Prostate (LEP) ● Laser Ablation of the Prostate (LAP) ● Transurethral Incision of the Prostate (TUIP) ● Condylomas ● Urethral strictures ● Lesions of External Gentalia ● Bladder Neck Incisions (BNI) ● Ablation and Resection of Bladder Tumors, and Ureteral Tumors . Endoscopic Fragmentation of Urethral, Ureteral, Bladder, and Renal Calculi ● Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Indications: ● Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones ● Endoscopic fragmentation of calculi ● Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology: Open and endoscopic gastroentery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: • Appendectomy • Angiodysplasia • Polyps • Colorectal Cancer • Biopsy • Telangiectasias • Gall Bladder Calculi • Telangiectasias of the Osler-Weber-Renu Disease • Biliary/Bile duct Calculi • Vascular Malformation ● Ulcers ● Gastric Ulcers ● Esophagitis ● Duodenal Ulcers ● Esophageal Ulcers ● Non Bleeding Ulcers . Varices . Pancreatits . Colitis . Hemorrhoids . Mallory-Weiss Tear . Cholecystectorny . Gastric Erosions . Benign and Malignant Neoplasm
Gynecology: Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories are portable thulium fiber lasers intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories generates non-ionizing radiation which is transferred to the relevant anatomical treatment site through surgical fibers that serve as the delivery vehicle from the laser energy generator to the treatment site.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes wireless (optional) and wired, three-pedal footswitches for hands-free control. The system can utilize an auxiliary video monitor to display operating parameters.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories front panel includes a surgical fiber connection port and a touchscreen with a user interface. The back panel includes electrical and interface cable ports. The Laser Console may be placed on an optional mobile cart.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes:
- Laser Console ●
- Footswitches, wired or wireless (optional) ●
- Surgical Fibers ●
- . Accessories:
- Power cord O
- O Video output cable
- Video adapter O
- Safety glasses O
- Fiber stripper O
- Fiber cleaver o
- Blast shield O
- O Interlock connector
- Mobile cart (optional) о
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories on emission wavelengths between 1920 and 1960 nm.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories can operate at a maximum power output of 60 watts and a maximum frequency output of 2400 Hz with a maximum pulse energy of 6 Joules.
The IPG Medical Family of Thulium Fiber Lasers must be operated with the IPG Family of Surgical Fibers. The surgical fibers are flexible optical fibers that deliver the laser energy to the target tissue. The IPG Family of Surgical Fibers are offered in a range of core diameters from 150 microns - 940 microns and include single use, reusable and ball tip options. The surgical fibers are the only patient-contacting components of the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories.
The provided text is a 510(k) Summary for the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and design verification testing. It does not describe an AI/ML-driven medical device, and therefore the specific questions regarding acceptance criteria, study details, and ground truth for an AI device cannot be answered from the provided text.
Specifically, there is no information about:
- A table of acceptance criteria and reported device performance for an AI/ML component.
- Sample sizes for a test set or its provenance for an AI/ML component.
- Number of experts or their qualifications to establish ground truth for an AI/ML component.
- Adjudication method for an AI/ML component test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for AI assistance.
- Standalone (algorithm-only) performance of an AI/ML component.
- The type of ground truth used for an AI/ML component (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set of an AI/ML component.
- How the ground truth for an AI/ML component's training set was established.
The document describes performance testing for a laser system and its accessories, not an AI/ML algorithm. The listed tests include:
- Electrical Safety and EMC (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1)
- Biocompatibility (e.g., ISO 10993-1, -5, -10, -11, -12)
- Packaging and Sterile Barrier (e.g., ISO 11607-1, -2, ISO 14644-1, -2, ISO 14698-1, -2, ISO 15223-1, F1886/F1886M-16, F1980-16, F88/F88M-15, F2096-11, ASTM D4169-16, ASTM D4332-14, ISTA 3A, 3B)
- Sterilization (Surgical Fibers) (e.g., ISO 11135, ISO 10993-7, ISO 11138-1, ISO 11737-1, -2, ISO 17665)
- Human Factors (e.g., IEC 62366-1, IEC 60601-1-6)
- Risk Management (e.g., ISO 14971, ISO 22442-1)
- Software (e.g., IEC 62304)
- Measuring Systems (e.g., BS EN ISO 10012:2003)
- Design Verification Testing for the laser system and surgical fibers
- Shelf-Life testing for the Surgical Fibers
- Side-by-Side Comparison Testing (bench and animal tissue testing and analysis)
The conclusion states that "All testing demonstrated that the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories met its design requirements." and "Comparative testing (bench and animal tissue testing and analysis) between the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories and the primary predicate and additional predicate devices showed equivalent device performance and tissue response." This indicates that the acceptance criteria were met by passing these various non-clinical engineering and performance tests, rather than through a clinical study or AI/ML performance evaluation.
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